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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGuardian System
Generic NameAcute coronary syndrome event detector
ApplicantCJ Healthtech Holdings, LLC
125 Shore Ct.
Unit 208a
North Palm Beach, FL 33408
PMA NumberP150009
Supplement NumberS013
Date Received06/14/2024
Decision Date06/21/2024
Product Code QBI 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150009
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